A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

NCT01490788 | Completed Phase 1 Results

• 1 other identifier: TNX-CY-F101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Mean Plasma Concentration (AUC) of Cyclobenzaprine

  Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.

  0 to 96 hours

• Incidences of Adverse Events

  Every adverse events occurring during the study period will be reported.

  Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)

Study Arms (3)

Treatment A

EXPERIMENTAL

1 x TNX-102 2.4 mg gelcap under fasting conditions

Drug: Treatment A

Treatment B

EXPERIMENTAL

1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions

Drug: Treatment B

Treatment C

ACTIVE COMPARATOR

1 x TNX-102 2.4 mg gelcap under fed conditions

Drug: Treatment C

Interventions

Treatment A DRUG

TNX-102 2.4 mg - 1 gelcap once under fasting conditions.

Also known as: cyclobenzaprine HCl

Treatment A

Treatment B DRUG

Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions

Also known as: cyclobenzaprine HCl

Treatment B

Treatment C DRUG

TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Also known as: cyclobenzaprine HCl

Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Non-smoker
• years old
• BMI \> 18.5 and \< 30.0
• With medically acceptable form of contraception (female only).

You may not qualify if:

• Any clinically significant abnormality or vital sign abnormalities
• Any abnormal laboratory test
• History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
• Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
• Positive pregnancy test, breastfeeding or lactating
• Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
• Participation in an investigational study within 30 days prior to dosing
• Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of \> 499 mL (within 56 days) prior to dosing.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (1)

PharmaNet, Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Interventions

cyclobenzaprine

Results Point of Contact

• Title: Greg Sullivan, MD
• Organization: Tonix Pharmaceuticals, Inc.

greg.sullivan@tonixpharma.com

Study Officials

• Denis Audet, MD

  PharmaNet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 13, 2011
• Study Start: November 18, 2011
• Primary Completion: December 30, 2011
• Study Completion: December 30, 2011
• Last Updated: September 11, 2019
• Results First Posted: November 2, 2018

Record last verified: 2019-09

Locations

CA (1)